Vascular access system with connector

ABSTRACT

A connector for fluidly coupling proximal and distal tubular segments of a fluid conduit is provided. In one embodiment, the connector can include a connector body having an outer surface defining a first outer perimeter and an inner surface defining a lumen. The connector can also include a connecting device having an open configuration and a plurality of closed configurations. The connecting device can include first and second members configured to engage each other to secure the fluid conduit to the connector. The connecting device can also include a plurality of closed configurations for securing fluid conduits of different sizes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and is a non-provisional of U.S.Provisional Patent Application No. 61/531,303, filed Sep. 6, 2011, andU.S. Provisional Patent Application No. 61/636,851, filed Apr. 23, 2012,which are both hereby incorporated by reference.

BACKGROUND

This application relates to a connector which can be included in asystem for connecting multiple portions of a fluid carrying conduit.

In the United States, approximately 400,000 people have end-stage renaldisease requiring chronic hemodialysis. Permanent vascular access sitesfor performing hemodialysis may be formed by creating an arteriovenous(AV) anastomosis whereby a vein is attached to an artery to form ahigh-flow shunt or fistula. A vein may be directly attached to anartery, but it may take 6 to 8 weeks before the venous section of thefistula has sufficiently matured to provide adequate blood flow for usewith hemodialysis. Moreover, a direct anastomosis may not be feasible inall patients due to anatomical considerations.

Other patients may require the use of artificial graft material toprovide an access site between the arterial and venous vascular systems.Patency rates of grafts are still not satisfactory, as the overall graftfailure rate remains high. Temporary catheter access is also an option.However, the use of temporary catheter access exposes the patient toadditional risk of bleeding and infection, as well as discomfort.

SUMMARY

Some or all of the above needs and/or problems may be addressed bycertain embodiments disclosed herein. For example, in one embodiment, asystem is provided for providing continuous flow of blood between twolocations in a patient's cardiovascular system. A blood conduit isprovided that has a distal portion and a proximal portion. The distalportion is adapted to be inserted into a blood vessel at an insertionsite and to be advanced therethrough to a location spaced apart from theinsertion site. The system is provided with a connector that has adistal portion adapted to be engaged with the proximal portion of theblood conduit and a tubular body extending proximally of the distalportion. The tubular body is adapted to be inserted into an end of avascular graft. The connector is provided with a connecting devicehaving an open configuration. The connecting device also has a firstclosed configuration providing a first gap between an inner surface ofthe connecting device and the tubular body and a second closedconfiguration providing a second gap between the inner surface of theconnecting device and the tubular body. The first gap accommodates agraft having an inner perimeter matching the outer perimeter of thetubular body and a first wall thickness. The second gap accommodates agraft having an inner perimeter matching the outer perimeter of thetubular body and a second wall thickness different than the first wallthickness. Continuous flow can be provided from grafts of different wallthicknesses through the connector and into the blood conduit.

Other embodiments, aspects, and features of the disclosure will becomeapparent to those skilled in the art from the following detaileddescription, the accompanying drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, which are notnecessarily drawn to scale.

FIG. 1 is a perspective view of an embodiment of a vascular accesssystem.

FIG. 2 is a plan view of an embodiment of a vascular access systemassembly including a connector, a strain relief structure, and avascular graft.

FIG. 3 is a perspective view of an embodiment of a connector in a closedconfiguration.

FIG. 4 is a perspective view of an embodiment of a connector in an openconfiguration.

FIG. 5 is an end view of an embodiment of a connector taken at 4-4 ofFIG. 3 in an open configuration.

FIG. 6 is a plan view of an embodiment of a connector in an openconfiguration.

FIG. 6A is a perspective view of an embodiment of a spring structure.

FIG. 7 is a plan view of an embodiment of a strain relief structure.

FIG. 8A is a perspective view of a connector device utilizing a proximallongitudinal motion of an outer ring to secure any of a range of bloodconduit components.

FIG. 8B is a perspective view of a connector comprising a clamshellconstruction that can be used to secure any of a range of blood conduitcomponents.

FIG. 8C is a perspective view of a connector having a sprung member tosecure any of a range of blood conduit components.

FIGS. 9A-9F illustrate example systems and method for facilitating aconnection.

FIG. 10 is a perspective view of an embodiment of a connector in an openconfiguration.

FIG. 11 is a perspective view of an embodiment of a strain reliefstructure.

FIGS. 12A-12F illustrate example systems and method for facilitating aconnection.

DETAILED DESCRIPTION

Improved hemodialysis and vascular access systems and methods have beendeveloped. In one broad sense, certain embodiments include a blood flowcomponent that can be used for outflow of blood from the system and acoupling or connecting device that can be used to secure an inflowconduit of the system relative to the outflow conduit. Secure connectionof the inflow and outflow components enable a continuous flow throughthe system, where the inflow and outflow components are in secure fluidcommunication with each other. Techniques for connecting the outflowcomponent with the connecting device are also provided. In variousembodiments, the connective device and assembly methods improve over,and/or build upon, the connecting means described in U.S. Pat. No.8,079,973, which is hereby incorporated by reference.

A proximal portion of the connecting device is provided in variousembodiments to enable fluid connection of the outflow component with anyof a variety of inflow components. The inflow components can be any of avariety of blood conduits that are able to be connected to the vascularsystem to receive blood into the vascular access system. Such bloodconduits can have a construction similar to a vascular graft made ofePTFE, Dacron, or other suitable materials. Other suitable materials caninclude a material that is biocompatible with an artery and has a non-or minimally thrombogenic characteristic. The inflow componentpreferably is adapted for long term attachment to an artery. The inflowcomponent preferably comprises a region suitable for repeated needleaccess. For example, a length of the inflow component can be configuredto be pierced by a needle to enable blood to be withdrawn from andreturned to the system. While packaging an outflow component with aconnector is convenient to the manufacturer, different end users mayhave different preferences regarding which inflow component to use. Forexample, some end users may prefer one material or manufacturer overothers for any of a variety of reasons.

Accordingly, to enable the outflow component to be used with a widevariety of grafts and other inflow components, connecting devices havebeen developed and are provided herein that are connectable to a varietyof grafts and other inflow components.

FIG. 1 illustrates one embodiment of a vascular access system 50 havinga plurality of components that can be assembled together to form a lumen60. The lumen 60 provides a blood conduit or pathway configured to shuntblood from a first vascular segment to a second vascular segment. Thevascular access system 50 has a proximal end 54 and a distal end 58 anda lumen 60 that extends between the proximal and distal ends 54, 58. Insome embodiments, the proximal end 54 can be adapted to couple with,e.g., attached to, a first vascular segment and the distal end 58 can beadapted to be coupled with, e.g., inserted into a second vascularsegment. The lumen 60 preferably extends between the proximal and distalends 54, 58. The lumen 60 can also be accessed from outside the patientto facilitate dialysis or other treatment.

In one embodiment, as illustrated in FIG. 1, the vascular access systemincludes a connector 70 adapted to fluidly connect a first conduit 62,such as an inflow component or graft, and a second conduit 66, such asan outflow component or catheter, to form the lumen 60. In certainembodiments, the first conduit 62 extends from the proximal end 54toward the distal end 58, and the second conduit extends from the distalend 58 toward the proximal end 54. The connector 70 can be positionedbetween the first and second conduits 62, 66 such that a distal portionof the first conduit 62 is configured to be connected to a proximalportion of connector 70 and a proximal portion of the second conduit 66is configured to be connected to a distal portion of connector 70. Theconnector 70 and/or conduits 62, 66 can be provided and/or integratedwith one or more connecting devices to connect or enhance the securityof connection between the first and second conduits 62, 66.

FIG. 2 illustrates a sub-assembly of one embodiment of a vascular accesssystem assembly similar to that of FIG. 1. FIG. 2 shows a systemincluding a connector 170 and an inflow component 162. The inflowcomponent 162 can take a variety of configurations, for example, havingwall thickness in a relatively wide range, but otherwise similar to avascular graft. The inflow component 162 is connected to and in fluidcommunication with a portion of a first end 154 of the connector 170 viaa connecting device 166. A portion of a second end 158 of the connector170 can be connected to an outflow component, such as a blood conduit orcatheter. The outflow component can be similar to the outflow component66, described in more detail in U.S. Pat. No. 8,079,973, which is herebyincorporated by reference. As illustrated in FIG. 2, in someembodiments, the second end 158 of the connector 170 can have a tubularstructure with one or more engagement features 168 to enhance thesecurity of connection or provide mechanical engagement between theconnector 170 and the outflow component. The engagement features 168 canhave enlarged outer diameters or perimeters greater than the diameter ofthe tubular structure of the second end 158 of the connector 170. Insome embodiments, the engagement features 168 can comprise one or morebarbs. As illustrated, in some embodiments, the engagement features 168can have conical shapes with the outer perimeter or diameter increasingfrom a first end to a second end of an engagement feature 168. In someembodiments, the connecting device 166 can have a clamshell structure.The term clamshell structure is a broad term intended to cover acombination of a plurality of members, at least one of which can pivotaway from and toward the other, wherein when pivoted together a closedconfiguration is formed, and is not limited to structures with clamshelltype shapes or edge-to-edge contact around a perimeter. For example, insome embodiments, the hinge-type mechanism can have arcuatefinger-shaped members or have members with outer diameters or surfacesthat are more angular or square in shape and inner diameters or surfacesmore tubular or cylindrical in shape. In this manner, the connectingdevice 166 may be any configuration that performs its intended function.

In some embodiments, as illustrated in FIGS. 2, 7, and 11 the system orassembly can be provided with one or more strain relief structures 164surrounding the inflow component 162 and/or an outflow component. Insome embodiments, the strain relief structure 164 comprises anelastomeric sleeve that can be slid over a portion of the first end ofthe connector and a coil that surrounds the inflow component. The sleeveenables the strain relief structure 164, which can be a coil or otherstructure reducing or minimizing strain on the inflow component by theconnector. The elastomeric properties allow the sleeve to couple withthe connector when it exhibits a range of outer diameters, depending onwall thickness of attached inflow component, as discussed in more detailbelow. In other embodiments, the strain relief structure 164 can beconfigured to have a mechanically varying inner profile that does notrely on elastomeric properties to accept larger and smaller structuresdue to the varying of the wall thickness or other transverse dimensionof the inflow component or connector. However, the elastomeric sleeve isa simple structure that requires few parts and thus is an elegantsolution to the problem of coupling a strain relief structure to theconnector, which can have different outer perimeters and configurationsin use.

The strain relief structure 164 reduces or minimizes kinking or pinchingof the inflow component 162. In some embodiments, the strain reliefstructure 164 can include both a resilient characteristic and a softinner surface. For example, a springy material or configuration, such asa nitinol coil can be provided to resist unwanted, unpredictabledeformation in the zone of the strain relief structure 164. Also, a softmaterial or construction, such as a silicone sleeve can be provided toisolate the inflow component 162 from pinching due to kinking. In someinstances, the sleeve can be slid over an end of the connecting device166 forming a friction fit with the connecting device 166 and a slip fitwith the inflow component 162. In other instances, the sleeve can beclamped within the connecting device 166 to form a mechanical connectionbetween the sleeve and the connecting device 166. As discussed above, insome embodiments, this can help prevent kinking or closing of the inflowcomponent 162 as it extends out from the connecting device 166.

FIG. 3 illustrates one embodiment of a connector 270. As illustrated,the connector 270 is in a closed configuration. In some embodiments, aconnecting device 266 can be integrated with the connector 270. In otherembodiments, the connecting device 266 can be a separate component fromthe connector 270. The connector 270 can be configured with a flange 282or protrusion to which a hinge structure 240, such as a pin can bemounted. The flange 282 can be configured as a radially projected memberof the connector 270, in some embodiments forming a widest profile ofthe connector 270.

The connecting device 266 can be provided with first and second members278, 280 that have first and second ends 246, 248 and 250, 252respectively. The first ends 246, 248 of the first and second members278, 280 of the connecting device 266 can be pivotably coupled with thehinge structure at the flange 282 of the connector 270. The second ends250, 252 (see FIG. 4) can be positioned or disposed away from the firstends 246, 248. The first and second members 278, 280 have a combinationof rigidity and flexibility to permit relatively easy coupling and verysecure connection therebetween.

Some flexibility in a direction parallel to the longitudinal axis of thelumen defined within the connector 270 can be provided by slots 276disposed adjacent to the second ends 250, 252 of each of the members278, 280. The slots 276 can start at the second ends 250, 252 and extendtoward the first ends 246, 248. As discussed further below, the slots276 enable teeth disposed on the second ends 250, 252 of the first andsecond members 278, 280 to be deflected axially by an amount sufficientto permit the teeth to move circumferentially past each other. The slotsare one example of an axial displacement feature, which can take otherforms, such as including channels or recesses positioned on at least aportion of a surface of the first and second members 278, 280. Invarious embodiments, the axial displacement feature can extend at leasta portion of the distance between the second and first ends 250, 252 and246, 248 of at least one of the first and second members 278, 280. Forexample, in one embodiment, the axial displacement feature can beconfigured to extend at least about 25% of the distance between thesecond and first ends 250, 252 and 246, 248 of at least one of the firstand second members 278, 280. More generally, these structures areconfigured to enable some degree of flex in the first and second members278, 280 while generally minimizing yield of these members so that theforce applied therebetween is known or within an acceptable range.

The connecting device 266 can have proximally extending shrouds 284, 286that extend out from a side of the first and second members 278, 280towards a first end 254 of the connector 270. The shrouds 284, 286 arediscussed in more detail in connection with FIG. 4 below. In someembodiments, the shrouds 284, 286 can be omitted, or otherwisesubstantially reduced, as discussed in more detail in connection withFIG. 10 below.

As discussed above, the connector 270 can have a tubular structure 244extend out towards a second end 258. The tubular structure 244 can beadapted to be connected with an outflow component, illustrated inFIG. 1. The tubular structure 244 can be provided with engagementfeatures 268 for secure attachment with the outflow component asdiscussed in greater detail in U.S. Pat. No. 8,079,973, previouslyincorporated by reference herein.

FIG. 4 illustrates one embodiment of the connector 270 in an openconfiguration. The first and second members 278, 280 of the connectingdevice 266 are configured to engage portions of an outer surface of aninflow component or graft (not shown) to secure it to the connector 270.A range of positions or closed configurations for the first and secondmembers 278, 280 are provided such that a range of thicknesses of graftscan be secured to the connector 270. The ability to accept ranges ofthicknesses enables the connector 270 to work with differentdistributions of products, e.g., having average wall thicknesses atleast at their distal ends that are significantly different. Asdiscussed elsewhere herein, this feature advantageously enables a systemincluding the connector 270 to be used in more settings and with variousdifferent products in a product line. In some embodiments, the secondends 250, 252 of the first and/or second members 278, 280 of theconnecting device 266 can be provided with protrusions, grippingstructures or teeth 296, 298 on mating surfaces that maintaincompressive force on the graft and connector in the closedconfigurations. The teeth 296, 298 can be formed along an arcuate bodyon the first and second members 278, 280, allowing a secured or lockedengagement at any position over an arcuate path of movement of the firstand second members 278, 280. As discussed above, first ends 246, 248 ofthe first and second members 278, 280 can be pivotably connected at oneaxis of rotation, such as by a pin 240.

In some embodiments, to facilitate engagement of the teeth 296, 298 someaxial displacement of at least a portion of at least one of the firstand second members 278, 280 can be provided. For example, the slot 276can enable the second ends 250, 252 of the first and second members 278,280 to deflect away from each other by an amount sufficient to enablethe teeth to slide past each other when so deflected. In one example,the slots 276 can enable the second ends 250, 252 of each of the firstand second members 278, 280 to deflect at least about one-half theheight of the teeth. More deflection may be provided in someembodiments, for example, if the first and second members 278, 280 areat least partially in the same transverse plane prior to being engaged.As such members come into engagement, a greater degree of deflection maybe provided. In some embodiments, less deflection may be suitable, suchas where the other components of the system have substantially tighttolerances and little deformation upon deflection. As discussed above,the first and second members 278, 280 have sufficient resilience suchthat when peaks of the teeth of the first member 278 arecircumferentially aligned with valleys between the teeth of the secondmember 280, the second ends 250, 252 of the first and second members278, 280 move axially toward each other by about the same amount thatthe first and second members 278, 280 are deflected by the teeth.

As illustrated in FIG. 4, in some embodiments, the connector 270 canhave a tubular structure 292 that extends from a first end 254 to asecond end 258. The tubular structure 292 can have a consistent orvariable diameter. A protrusion or shoulder 288 can be circumferentiallypositioned around the tubular structure 292 between the first and secondends 254, 258. In some embodiments, the pin 240 can pass through aportion of the shoulder 288. A portion of the tubular structure 292 canextend from the shoulder 288 to the first end 254 of the connector 270.An inflow component can be slid in an axial direction from the first end254 to the second end 258. The inflow component can be slid over thetubular structure 292 until an end of the inflow component abuts withthe shoulder 288. Further discussion of methods of coupling thesestructures are discussed below in connection with FIGS. 9A-9F and12A-12F.

As discussed above, and illustrated in FIG. 4, the connector 270 can beprovided with engagement features to ensure a secure connection with theinner surface of a graft or other inflow component. For example, thetubular structure 292 can have one or more engagement features 290, suchas, for example, ribs, barbs, or a combination thereof. In someembodiments, the engagement features 290 are inclined toward the firstend 254 of the connector 270 such that a proximal ridge is presented toengage the inner surface of the outflow component. The engagementfeatures 290 can be positioned circumferentially around the tubularstructure 292 and have a conical shape. The diameters of sides of theengagement features 290 facing one end of the connector 270 can begreater than the diameters of the sides facing an opposite end of theconnector 270. In some embodiments, the one or more engagement features290 are of equivalent diameters. In other embodiments, the engagementfeatures 290 can increase in diameter towards one end of the connector270, such as the second end 258.

In some embodiments, as illustrated in FIG. 4, the connecting device 266can have proximally extending shrouds 284, 286. Inner surfaces of theshrouds 284, 286 can be provided with engagement features 294 that caninclude protrusions, channels, ribs, or combinations thereof. Theseengagement features 294 can also assist in ensuring a secure connectionbetween an outer surface of a graft and the connector 270. Theseengagement features also reduce the surface area of material beingcompressed as the first and second members 278, 280 are engaged to helpreduce the force required to be applied to the mechanism for a givenamount of compression of (or pressure on) the graft material. When usedin a surgery to apply a system like the vascular access system 50,reduced manual force to connect the components reduces fatigue for thesurgeon, which can benefit the patient, the surgeon, and make theprocedure simpler. In some embodiments, a space or gap is providedbetween the shrouds 284, 286 when an outer surface of a graft that issecured to the connector 270 when the connecting device is in a closed,secured, or locked configuration. The size of the gap or space betweenthe shrouds 284, 286 can depend on the relative position of the firstand second members 278, 280. The gap or space can thus be selected orcustomized to the thickness of a particular inflow component, e.g.,graft. A thicker graft will be accommodated within the shrouds 284, 286when a larger gap is provided therebetween in a closed or lockedconfiguration of the connector 270, and a thinner graft can beaccommodated within the shrouds when a smaller gap (or no gap) isprovided therebetween in a closed or locked configuration.

In the illustrated embodiment, the shrouds 284, 286 have asemi-cylindrical configuration and extend axially between an end of thefirst and second members 278, 280 facing the end 254 of the connector270 and the end 254. The shrouds 284, 286 can extend in an arcuate pathalong a portion of first and second members 278, 280 and rotate togetherwith the first and second members when they move between open and closedconfigurations. In some embodiments, the shrouds 284, 286 can be omittedand/or substantially reduced in length.

In some embodiments, a further safety mechanism can be provided on thefirst and second members 278, 280 to ensure sufficient engagement of thegripping structures 296, 298. As shown in FIG. 2, protrusions 172 and174 can be located at second ends of the first and second members. Theseprotrusions 172, 174 are the first structures on the first and secondmembers 278, 280 to come into contact with each other. The protrusions172, 174 deflect the second ends 250, 252 of the first and secondmembers 278, 280 apart and hold the first and second members apart afterinitial engagement of the second ends until the second ends slide pasteach other and overlap each other by a minimum amount before the teeth296, 298 (or other engagement feature) come into engagement. In someembodiments, the first and second members can be held apart by theprotrusions 172, 174 until the gripping structures or teeth move pasteach other at least a minimum number of teeth, such as, for example, atleast two teeth. These protrusions may also serve as pry points if theconnection is intended to be capable of being undone.

FIGS. 5 and 6 illustrate a plan view and an end view, respectively, ofan embodiment of the connector 270. In the end view, an open position ofthe connecting device 266 is shown. This view also illustrates thearcuate shape, e.g., semi-circular configuration of the first and secondmembers 278, 280. FIGS. 5 and 6 show, in particular, the first andsecond members 278, 280 pivotably connected at a hinge structure, suchas pin 240, of flange 282 with shrouds 284, 286 extending out fromsurfaces of the first and second members.

FIGS. 6 and 6A illustrates an example spring 800 that may be positionedabout the hinge of the connector 270. For example, the center portion ofthe spring 800 may include a coil 802. In some embodiments, the coil 802may be positioned around the pin 240 of the hinge. In one embodiment,end portions 804, 806 of the spring 800 may engage the first and secondmembers 778, 780, respectively, of the connector 270. That is, in someinstances, the spring 800 may be configured to maintain the connector270 in the open configuration as depicted in FIG. 6. In other instances,the spring 800 can be configured to apply a constant force between theteeth 296, 298 formed along the arcuate body of the first and secondmembers 278, 280 when the connector 270 is in the closed configuration.The constant force between the teeth 296, 298 can provide a secured orlocked engagement when the connector 270 is in the closed configuration.

FIG. 7 illustrates one embodiment of the strain relief structure 164discussed above. A distal portion 140 of the strain relief structure164, which has an elastomeric configuration, can include a cylindricalring of silicones or polyurethanes. In one embodiment, the silicone canhave a hardness of approximately 50 durometer (Shore A). Further detailsof the elastomeric configuration are discussed above. A proximal portion142 of the strain relief structure 164 can comprise a resilientstructure, such as a nitinol coil defining a lumen therein ofsubstantially constant diameter. Other materials that can be usedinclude PEEK, stainless steel, MP35N and other similar metals. Asdiscussed above, a sleeve, such as silicone, can be disposed within thestrain relief structure 164, which may have an outer diametersubstantially the same as the inner diameter of the coil. In someembodiments, as discussed below with reference to FIG. 11, the sleevemay extend beyond the distal end of the coil. The coil preferably iswound sufficiently tightly such that adjacent turns of the wires toucheach other. This structure substantially prevents compression of thecoil, which during implantation, substantially prevents tissue frombeing caught between adjacent turns of the coil or prevents the tissuefrom compressing the coil axially. The strain relief structure 164 canhave a length 144 of increasing diameter. The increasing diameter length144 can enable this portion of the strain relief structure 164 to bepositioned over the tubular structure 292 of the connector 270. In oneembodiment, the sleeve disposed in the strain relief structure 164 alsohas an increasing inner diameter to accommodate the tubular structure292 of the connector 270 as well as the inflow component. In anotherembodiment, the sleeve may include a constant diameter, which may beclamped within a portion of the connecting device 266.

FIGS. 8A-8C illustrate alternative embodiments of a connecting device.FIG. 8A illustrates an embodiment of a connecting device 410 in which asimple longitudinal sliding action firmly secures any graft or otherinflow component (not shown) to a connector 414.

The connecting device 410 includes an outer ring 418 and an inner forceapplying member 422. The inner force applying member 422 can be a colletin one embodiment. The force applying member 422 can include multiplefingers 426 that engage a portion of the underlying graft or otherinflow component. Initially the fingers 426 are in an open position orconfiguration (as shown) to allow insertion of the inflow component. Theinflow component may be a tubular body with an inner circumferencelarger than a proximal end 430 of the connector 414 and an outercircumference less than the relaxed inner circumference of the forceapplying member 422. The graft or inflow component can be slid distallyover the proximal end 430 of the connector 414. In one embodiment acentral flange 434 is provided on the connector 414. A confirmation ofproper placement of the inflow component is provided by configuring theflange 434 with an outer circumference greater than at least the innercircumference of the inflow conduit such that the inflow conduit can bebutted up to the central flange 434. In one method of connection,relative distal motion of the inflow component over the proximal end 430is provided until the distal end of the inflow component is pushed upagainst the flange 434.

The outer ring 418 is configured to anchor or secure the inflowcomponent to the connector 414. For example, the outer ring 418 can beadvanced proximally relative to the force applying member 422 toward theend of the fingers 426. In FIG. 8A, a plurality of fingers 426 aredisposed about the proximal perimeter of the force applying member 422.The fingers 426 are shown toward the upper right in FIG. 8A. Oneconfiguration for securing the inflow component between the forceapplying member 422 and the connector 414 is to provide a taperedinterface between the outer ring 418 and fingers 426 or between theouter ring 418 and the connector 414. The tapered interface could beinclined in the proximal direction to progressively larger diameter,width or circumference to provide a progressively greater friction forcebetween the force applying member 422 and the inflow component. Theincreasing force can also be applied by this technique between theinflow conduit and the connector 414 proximal of the flange. Theseforces cause the force applying member 422 to grip and secure the inflowconduit to the connector.

By providing a suitable taper, the point of initial engagement ispermitted to vary depending on the wall thickness of the underlyinggraft or other inflow component. The design above utilizes frictionbetween the outer ring 418 and force applying member 422 to maintain anengaged configuration. In certain embodiments, the tapered surface andaxial or longitudinal movement can be replaced with or supplemented bythreads, a latch, a spring mechanism, or a combination thereof.

The underlying connector 414 can be titanium or other strong and wellmachineable material. If the force applying member 422 is a collet, itcan be formed of a spring metal or polymer with sufficient flexibility.Flexibility is desired to allow the fingers to deflect without too highof force. Possible materials for the collet include PEEK,polyetheylenes, and other polymers. Metals with such as nitinol orstainless steel may be suitable. The material may be designed to yieldor not depending on the thickness of the fingers. The outer ring 418 maybe any material with high enough strength to maintain a small profile(thin wall). Some consideration for friction may be given with theunderlying collet interface depending on ease of activation andresistance to sliding post connection desired.

FIG. 8B illustrates another embodiment having a hinge-type configuredmechanism or connecting device 500. One example of a hinge-typemechanism is a clamshell. In this design, a plurality of overlappingfingers 510 is provided to engage portions of an outer surface of theinflow component. For example, two fingers 510A, 510B can be providedwhere each overlaps approximately one-half of a short distal length ofan outer surface of the inflow component, which is disposed between thefingers and the connector 514. Initially the fingers 510A, 510B are inan open position or configuration. Thereafter, they are moved to aclosed configuration, as shown in FIG. 8B. In the open configuration,the inflow component can be advanced up to the flange 534, as discussedabove. Thereafter, the fingers 510A, 510B can be brought together toapply a compression force onto the distal length of the inflow componentdisposed between the finger 510A, 510B and the body of the connector514. In some embodiments, the fingers 510A, 510B move past, overlap,and/or slide past each other in order to engage each other and/or theinflow component in a closed configuration. In particular, the graft (orother inflow component) is slid on, then confirmed to be butted up tothe central flange 534, and the fingers 510A, 510B pinched together toclose and engage the graft. The point of initial engagement variesdepending on the wall thickness of the underlying graft. A range ofpositions of the fingers 510A, 510B providing sufficient securement isprovided such that a range of thicknesses and compressibility of theinflow component can be accepted. The fingers can include teeth 524 orother gripping structures on mating faces that provide for a positivelock and maintain the force upon the graft (within one tooth) that wasprovided. The teeth 524 can be formed in an arcuate path and slide pasteach other to come to a secured engagement at any position over thearcuate path.

The underlying connector component can be formed as discussed above. Thefingers 510A, 510B may be a metal or polymer with the tradeoff betweenstrength and flexibility. Flexibility is desired to allow the teeth toslip past each other without too high of force. Strength is required tomaintain engagement and not strip the teeth. PEEK may be a suitablematerial.

In the illustrated embodiment, the teeth 510A, 510B are pivotablyconnected to the flange 534 at an axis of rotation. A pin 518 can beprovided for such pivotable motion.

FIG. 8B illustrates that in some embodiment, other hinge-type connectordevices can be configured without a shroud. This can result in ease ofand less costly manufacturing. In some embodiments, the connector deviceas illustrated in FIG. 8B, can be combined with the strain reliefstructure 164 as described above.

FIG. 8C illustrates an embodiment of a connecting device 600 in which amember 610 has a free state for clamping an inflow component to theconnector 614. In particular, the member 610 can be a sprung memberconfigured to move toward a smaller circumference or pinchingconfiguration when released. In one form, the member 610 includes twoU-shaped halves (in cross-section) that each engage a portion of theunderlying graft. The natural state for the sprung member is in theclosed position (as shown). During installation of the graft, the sideopposite the U members (left end in FIG. above) is pinched. Thispinching action causes the member to deform and the U members toseparate and allow insertion of the graft material or other inflowcomponent.

While remaining pinched at the distal end, the graft or other inflowcomponent can be slid distally then confirmed to be butted up to thecentral flange similar to the techniques discussed above. Thereafter,the member 610 can be released at the distal end. The natural state ofthe member forces U shaped halves inward at the proximal end andtogether to close and engage the graft. The point of initial engagementvaries depending on the wall thickness of the underlying graft. Thedesign above is shown with an outer clear polymer sleeve 618 that may bebeneficial for biocompatibility or ergonomics.

The underlying connector component may be preferably titanium or otherstrong and well machineable material. The sprung member may be springmetal or polymer with a requirement being flexibility and resistance toyielding. Possible materials for the sprung member include nitinol,spring stainless steels, and possibly polymers. The outer sleeve (ifprovided) may be constructed of silicone, polyurethane, or othermaterials disclosed herein or otherwise known in the art.

Although the foregoing connecting device can secure an inflow componentto the connector 614, additional barbs may be provided to increaseretention force of the graft or inflow component. These may be on theunderlying portion of the connector (to engage ID of graft), or on theother portions, e.g., on the U spring members, fingers, or colletfingers (to engage the OD of graft).

The nominal inner diameter of the above devices may be adapted andsuitable for use with any graft or inflow component used for vascularaccess. Examples include 6 mm ID grafts as well as 5 and 7 mm ID grafts.

Radiopaque materials may be included within the connector devicesdescribed herein. Examples of suitable material include but are notlimited to: platinum, tantalum, tungsten, gold, palladium, iridium,barium sulfate, and any combination thereof. These marking materials maybe doped into the molded materials or in the form of rings, patches,plates, wire, or other shapes 149 as illustrated in FIG. 1. They may bedistributed in the entire device or at one or both ends of the device oranywhere in between.

In some instances, a kit for accessing blood from a patient'svasculature can be provided that can include, among other things, one ormore of the components disclosed herein. For example, the kit caninclude an outflow component connector for interconnecting the inflowand outflow components, a connecting device, and a dilator to assist inexpanding an inflow component for attachment to the connector. Othercomponents may be included in the kit. The kit may be sterilized.

FIGS. 9A-9F illustrate one embodiment of attaching an inflow component362 to a first end 354 of a connector 370. A second end 358 of theconnector 370 can be configured to be connected to an outflow component(schematically shown in FIG. 1). FIG. 9A illustrates an initial step ofplacing the strain relief structure 364 over the inflow component 362.The arrow A illustrates one technique in which a proximal portion 342which can include a coil is advanced over a distal portion 361 of theinflow component 362. Preferably a distal portion 340 of the strainrelief structure 364 is moved to a location proximal of the distalportion 361 of the inflow component 362.

The inner diameter or perimeter of the inflow component 362 can match orbe substantially equivalent to the outer diameter or perimeter of theconnector 370. FIG. 9B illustrates that a dilator 302 can be used toradially expand one end of the inflow component 362, e.g., the distalportion 361 thereof. The radial expansion may be due primarily toelastic deformation. The dilator 302 includes a distal zone 302A that isconfigured for gripping by the user and a proximal zone 302B that isconfigured for insertion into the inflow component 362. The proximalzone 302B is tapered to facilitate easy insertion of the dilator 302into the inflow component 362. The tapered feature of the proximalportion 302B also ensures gradual enlargement of the lumen of the inflowcomponent 362 to a size that will provide a good connection to theconnector, as discussed further below. The dilator 302 preferably alsoincludes a depth limiter 302C, which can be configured as a shoulder.The depth limiter 302C prevents over-insertion of the dilator 302 intothe inflow component 362, which could cause over-enlargement of theinflow component 362. Over enlargement can compromise the security ofthe connection to the connector, as discussed below.

FIG. 9B illustrates the use of the dilator by arrows B1 and B2. B1illustrates that the dilator is first inserted into the lumen of theinflow component 362 up to the depth limiter 302C. B2 illustrates thatthe dilator 302 is then removed from the inflow component 362, providingsuitable size and shape of the distal portion 361 thereof. In apreferred embodiment, the dilator 302, at least on the outer surface ofthe proximal zone 302B, is formed of a highly lubricious material, suchas polytetrafluoroethylene (PTFE), which has been found to significantlyfacilitate the dilation process.

FIG. 9C illustrates that after the inflow component 362 has beendilated, it can be slid in the direction of the arrow C over the firstend 354 of the connector 370 in an axial direction towards the secondend 358. The size and shape provided by the dilator 302 preferably isone that provides a tight fit, e.g., an interference fit, between theinflow component 362 and the first end 354 of the connector 370. In somegrafts, the inflow component 362 will respond to the dilating processillustrated in FIG. 9B by at least some elastic recoil or recovery,which provides at least a partial seal between the inflow component 362and the first end 354 of the connector 370. In other embodiments, a sealcan be imposed between these structures by a clamping structure, such asby closing the clam shell members discussed above. The inflow component362 can be slid axially until one end thereof abuts with a shoulder 388.Engagement features 390 similar to those discussed above in connectionwith the connector 270 can be positioned on an outer surface of theconnector 370 to mechanically engage with the inner surface orengagement features (not shown) positioned on an inner surface of theinflow component 362.

In some embodiments, first and second members 378, 380 of the connectingdevice 366 can then be actuated, e.g., pinched or pushed together, suchthat the gripping structures or teeth 396, 398 on respective matingsurfaces of the first and second members 378, 380 engage with eachother. This is illustrated by the arrows D in FIG. 9D. Portions of thefirst and second members 378, 380 can be moved past, slid past oroverlapped with each other until a closed configuration and secureconnection between the inflow component 362 and connector 370 isrealized. A safety structure can be provided on the connector 370 torequire at least a minimal actuation to ensure sufficient amount ofengagement between the engagement features on the first and secondmembers 378, 380. Surfaces 384, 386 of the connecting device can alsohave engagement features 394 positioned on an inner surface to providefurther mechanical engagement with the outer surface of the inflowcomponent 362.

As illustrated in FIG. 9E, there can be a gap or space 400 between endsof shrouds 384, 386 when the connecting device is in a closedconfiguration or position. The gap or space 400 may be larger or smallerdepending on characteristics, such as wall thickness, of the inflowcomponent 362. In some embodiments, the shrouds 384, 386 can have edges402, 404 that extend longitudinally in a direction parallel to alongitudinal axis of the connector 370. The gap 400 can extendcircumferentially between the two edges 402, 404 when the connectingdevice is in a closed configuration.

FIG. 9F illustrates one embodiment of installing a strain reliefstructure 364 over a proximal end 314 of the connecting device 366. Inone technique, a friction fit is formed between the strain reliefstructure 364 and the connecting device 366 and a slip fit between thestrain relief structure 364 and the inflow component 362 for strainrelief. The strain relief structure 364 helps prevent kinking orcollapsing of the inflow component 362 as it extends from the connectingdevice 366. The strain relief structure 364 can be slid, as illustratedby the arrow F, over a distal section of inflow component 362 toward thedistal end thereof, which is secured to the connecting device 366 in aclosed configuration. This sliding motion is in a direction towardssecond end 358, and continues until it reaches the proximal end 314 ofthe connecting device 366. For example, a distal end of the strainrelief structure, such as an elastic sleeve, can be slid over the outersurfaces of shrouds 384, 386 of the connecting device 366 to form afriction fit thereon.

FIG. 10 illustrates another embodiment of the connector 270 in an openconfiguration. In the embodiment of the connector 270 as depicted inFIG. 10, the shrouds 284, 286 are omitted or otherwise substantiallyreduced as compared to the embodiment of the connector 270 depicted inFIG. 4. For example, in some instances, the connector 270 generally doesnot include proximally extending shrouds that extend out from a side ofthe first and second members 278, 280 towards a first end 254 of theconnector 270. In other instances, however, the connector 270 mayinclude proximally extending shrouds that slightly extend out from aside of the first and second members 278, 280 towards the first end 254of the connector 270. That is, the shrouds may only partially extend outfrom a side of the first and second members 278, 280 towards the firstend 254 of the connector 270, but may not extend all the way to thefirst end 254 of the connector 270.

Still referring to FIG. 10, in one embodiment, the first and secondmembers 278, 280 of the connecting device 266 are configured to engageportions of an outer surface of a distally extending sleeve of a strainrelieve device positioned about an inflow component or graft (not shown)to secure it to the connector 270. A range of positions or closedconfigurations for the first and second members 278, 280 are providedsuch that a range of thicknesses of sleeves or grafts can be secured tothe connector 270. In some embodiments, the second ends 250, 252 of thefirst and/or second members 278, 280 of the connecting device 266 can beprovided with protrusions or gripping structures, such as teeth 296,298, on mating surfaces that maintain compressive force on the sleeveand/or graft when the connector is in the closed configurations. Theteeth 296, 298 can be formed along an arcuate body on the first andsecond members 278, 280, allowing a secured or locked engagement at anyposition over an arcuate path of movement of the first and secondmembers 278, 280. In some instances, the first ends 246, 248 of thefirst and second members 278, 280 can be pivotably connected at one axisof rotation.

In some embodiments, to facilitate engagement of the teeth 296, 298 someaxial displacement of at least a portion of at least one of the firstand second members 278, 280 can be provided. For example, the slot 276can enable the second ends 250, 252 of the first and second members 278,280 to deflect away from each other by an amount sufficient to enablethe teeth to slide past each other when so deflected. In someembodiments, the connector 270 can have a tubular structure 292 thatextends from a first end 254 to a second end 258. The tubular structure292 can have a consistent or variable diameter. A protrusion or shoulder288 can be circumferentially positioned around the tubular structure 292between the first and second ends 254, 258. In some embodiments, the pin240 (see FIG. 5) can pass through a portion of the shoulder 288. Aportion of the tubular structure 292 can extend from the shoulder 288 tothe first end 254 of the connector 270. An inflow component can be slidin an axial direction from the first end 254 to the second end 258. Theinflow component can be slid over the tubular structure 292 until an endof the inflow component abuts with the shoulder 288. Similarly, a sleevecomponent of a strain relieve device can be slid in an axial directionfrom the first end 254 to the second end 258. The sleeve can be slidover the tubular structure 292 and/or the inflow component until an endof the sleeve abuts with the shoulder 288. Further discussion of methodsof coupling these structures are discussed below in connection withFIGS. 12A-12F.

The connector 270 can be provided with engagement features to ensure asecure connection with the inner surface of a graft or other inflowcomponent. For example, the tubular structure 292 can have one or moreengagement features 290, such as, for example, ribs, barbs, or acombination thereof.

FIG. 11 illustrates one embodiment of the strain relief structure 164for surrounding an inflow component or an outflow component. A distalportion 140 of the strain relief structure 164 can include a sleeve 146extending therefrom. That is, in some embodiments, the sleeve 146 mayextend beyond the distal end of the coil. In some instance, the sleeve146 can be disposed at least partially within the strain reliefstructure 164, which may have an outer diameter substantially the sameas the inner diameter of the coil. In other instances, the sleeve 146may not be disposed within the strain relief structure 164 and may onlyextend from the coil. In some embodiments, the sleeve may be silicone. Aproximal portion 142 of the strain relief structure 164 can comprise aresilient structure, such as a nitinol coil, defining a lumen therein ofsubstantially constant diameter. In some embodiments, the strain reliefstructure 164 can have a length 144 of increasing diameter. Theincreasing diameter length 144 can enable this portion of the strainrelief structure 164 to be positioned over the tubular structure 292 ofthe connector 270. In one embodiment, the sleeve disposed within thestrain relief structure 164 can also have an increasing inner diameterto accommodate the tubular structure 292 of the connector 270 as well asthe inflow component. In another embodiment, the sleeve may include aconstant diameter. The strain relief structure 164 reduces or minimizeskinking or pinching of the inflow component 162.

FIGS. 12A-12F illustrate one embodiment of attaching an inflow component762 to a first end 754 of a connector 770. A second end 758 of theconnector 770 can be configured to be connected to an outflow component.FIG. 12A illustrates an initial step of placing the strain reliefstructure 764 over the inflow component 762. The arrow A illustrates onetechnique in which a proximal portion 742, which can include a coil andan inner sleeve 146, is advanced over a distal portion of the inflowcomponent. Preferably a distal portion 740 of the strain reliefstructure 764 is moved to a location proximal of the distal end of theinflow component 762.

The inner diameter or perimeter of the inflow component 762 can match orbe substantially equivalent to the outer diameter or perimeter of theconnector 770. In some instances, it is advantageous to have the innerdiameter of the inflow component 762 match or be almost the same as theinner diameter of the connector 770 to keep the inner profile as smoothas possible between the two components. In such instances, this mayrequire the use of the dilator (discussed below) or other means forstretching an end of the inflow component 762. Moreover, the innerdiameter or perimeter of the sleeve 746 can match or be substantiallyequivalent to the outer diameter or perimeter of the inflow component762. FIG. 12B illustrates that a dilator 702 can be used to radiallyexpand one end of the inflow component 762, e.g., the distal endthereof. The dilator 702 includes a distal zone 702A that is configuredfor gripping by the user and a proximal zone 702B that is configured forinsertion into the inflow component 762. The proximal zone 702B istapered to facilitate easy insertion of the dilator 702 into the inflowcomponent 762. The tapered feature of the proximal portion 702B alsoensures gradual enlargement of the lumen of the inflow component 762 toa size that will provide a good connection to the connector 770. Thedilator 702 preferably also includes a depth limiter 702C, which can beconfigured as a shoulder.

FIG. 12B illustrates the use of the dilator by arrows B1 and B2. B1illustrates that the dilator is first inserted into the lumen of theinflow component 762 up to the depth limiter 702C. B2 illustrates thatthe dilator 702 is then removed from the inflow component 762, providingsuitable size and shape of the distal end thereof. With at least theePTFE based grafts, it may be beneficial to dilate to a larger diameterthan the outer diameter of the connector to account for recoil. Also,recoil is a time dependent function and, therefore, may be enable thedilated portion of the graft to initially be easily slid on theconnector; the dilated portion may then tighten down to some level. Inone example embodiment, the outer diameter of the dilator may be 0.265″and the outer diameter of connector may be 0.236″ at the peak of barbs.Dilators with smaller outer diameters may result in interference (i.e.,less than 0.236″ graft inner diameter) before the graft is positionedover the connector. Even the 0.236″ can have slight interference. Insome instances, interference may be tolerated as long as it does notbecome too difficult to advance the graft over the connector. Sometimesa second dilation is beneficial.

FIG. 12C illustrates that after the inflow component 762 has beendilated, it can be slid in the direction of the arrow C over the firstend 754 of the connector 770 in an axial direction towards the secondend 758. The size and shape provided by the dilator 702 preferably isone that provides a tight fit, e.g., a slight interference fit, betweenthe inflow component 762 and the first end 754 of the connector 770. Theinflow component 762 can be slid axially until one end thereof abutswith a shoulder 788. Engagement features 790 similar to those discussedabove in connection with the connector 770 can be positioned on an outersurface of the connector 770 to mechanically engage with the innersurface or engagement features (not shown) positioned on an innersurface of the inflow component 762. Also, the material of the dilatormay have an effect on certain grafts, such as for example non ePTFEgrafts. For example, certain grafts will not slide over other plasticswith higher coefficients of friction but will slide over the PTFEmaterial dilator. Since ePTFE grafts are inherently lubriciousthemselves, the material of the dilator may be less important for them.

FIGS. 12D and 12E illustrate that after the inflow component 762 is slidover the first end 754 of the connector 770 to abut with the shoulder788, the strain relief structure 764 can also be slid axially (in thedirection of arrow D) over the first end 754 of the connector 770. Thatis, the strain relief structure 764 can be slid axially over the inflowcomponent 762 towards the second end 758 until the distal end of thesleeve 746 abuts with the shoulder 788. In this manner, the sleeve 746may be positioned within the connector 770.

In some embodiments, first and second members 778, 780 of the connector770 can then be actuated, e.g., pinched or pushed together, such thatthe gripping structures or teeth 796, 798 on respective mating surfacesof the first and second members 778, 780 engage with each other. This isillustrated by the arrows E in FIG. 12E. Portions of the first andsecond members 778, 780 can be moved past, slid past, or overlapped witheach other until a closed configuration and secure connection betweenthe inflow component 762, the strain relief structure 764, and theconnector 770 is realized.

FIG. 12F illustrates one embodiment of installing a strain reliefstructure 764 over a proximal end 754 of the connecting device 766. Inone technique, at least a portion of the sleeve 746 of the strain reliefstructure 764, along with at least a portion of the inflow component 762may be clamped, pinched, locked, or a combination thereof by the firstand second members 778, 780 of the connector 770. That is, the sleeve746 may be secured within the connective device 766 by the first andsecond members 778, 780 and/or by the shrouds 284, 286 (see FIG. 4) ifpresent.

As discussed above, the aforementioned embodiments allow the user (e.g.,a surgeon) to utilize a standardized outflow component and connectorsystem with any commonly available graft or inflow component of theirchoosing. This will allow surgeons to use grafts they have the mostexperience with and developed implantation skills for.

Another advantage is allowing a standardized outflow component andconnector system to be used with grafts capable of being accessed eitherearly or instantly. This eliminates the need for a temporary dialysiscatheter while the graft is incorporating into the body. Thisenhancement reduces the risk of infection with temporary dialysiscatheters, which are common and costly in hemodialysis. Some examples ofsuch structures are discussed in US 2007/0167901A1, which was publishedon Jul. 19, 2007, which is hereby incorporated by reference.

The foregoing method of connecting an inflow component to any of theconnectors herein can be embedded within a broader method of applyingsuch a device to a patient. Such a method can involve accessing a veinin the patient into which an outflow component is to be inserted. Forexample, a jugular vein could be accessed in such a method. The distalend of the outflow component can be positioned distant from the accesssite, e.g., at any location between the access site to a chamber of theheart.

The proximal end of the outflow component can thereafter be positionedat any suitable anatomical location, e.g., at the nearest delta-pectoralgroove. Such positioning of the proximal end of the outflow componentcan be achieved in any suitable manner, such as by tunnelingsubcutaneously the proximal end from adjacent to the venous insertionsite to adjacent to the delta-pectoral groove.

The broader method can also include coupling the proximal end of aninflow component with a vascular segment different from the insertionsite, which can be a jugular vein. The inflow component can be coupledwith a different vascular segment, e.g., a brachial artery by anysuitable technique. One technique involves suturing the proximal end tothe artery, for example producing an end-to-side anastomosis. Attachmentof the proximal end of the inflow component can be performed through asecond incision formed through the skin adjacent to the vascular segmentto which the inflow component is to be connected. After connecting theinflow component, the distal end of the inflow component can betunneled, e.g., subcutaneously to an anatomical location suitable forcoupling to the outflow component, e.g., to the delta-pectoral groove,where a third incision can be formed.

Once distal and proximal portions of the inflow and outflow componentsrespectively are located at a connection zone (e.g., delta-pectoralgroove), connection of these components can be achieved using theconnector systems and methods discussed above. In one convenienttechnique, a short length of a distal portion of the inflow component islifted out of the patient through the third incision and a short lengthof a proximal portion of the outflow component is lifted out of thepatient through the third incision. The proximal end of the outflowcomponent is advanced over the distal tubular structure of the connectorincluding the engagement features 168 (or similar, as discussed herein).The distal end of the inflow component is advanced over the proximaltubular structure of the connector. If present, the shrouds are closedaround a length of the sleeve and/or inflow component extendingproximally from the distal end thereof, as discussed above. A variety ofmethods of this type are discussed in general in U.S. Pat. No.7,762,977, which is hereby incorporated by reference herein for thepurpose of elaborating on these techniques, and for all other purposes.

The foregoing devices and variants thereof enable the provision of avascular access system. The inflow component can be attached by anymeans to an artery by suturing or otherwise arterialized. In otherembodiments, the proximal end of the inflow component is attached by anexpandable member, which can be self-expanding or balloon expandable. Aself-expanding version can include a sinusoidal circumferential memberadapted to be enlarged to at least the inner size of the artery. Thisenlargement enables a proximal portion of the inflow conduit to expandtoward the inner wall of the artery, e.g., to be pressed into engagementwith an internal segment of an artery. Another technique forarterializing the inflow component involves providing a couplingstructure, which can be one or more stent-like structures, as discussedin US 2009/0076587A1, published Mar. 19, 2009, which is incorporated byreference herein in its entirety. For example, at least a portion of theinflow component, e.g., including at least a portion of the couplingstructure, can be deployed within the vessel and the remainder of theinflow component can extend from the vessel to the connector.

A portion of the outflow component is adapted to be inserted within avein at an insertion site. The outflow component can have an outsidediameter which is less than an inner diameter of the vein and can haveat least one opening in an end thereof with at least one of the openingsin the catheter section to be disposed distant from the insertion site.For example, an outlet can be in the heart.

In operation, blood flows from the artery through the catheter and isreturned to the venous side of the circulatory system through an openingin the outflow component. The system preferably provides laminar bloodflow between the artery and the vein. In certain applications, bloodflows through the vein uninterrupted around at least an outer portion ofthe outflow component.

Access to the system can be provided in any suitable way, such as byproviding a needle having a first end coupled to a hemodialysis deviceand having a second end adapted for insertion directly into the inflowcomponent. Blood may thereby be shunted from the vascular access deviceto a dialysis device and back to the patient's circulatory system.

Although disclosed in the context of certain preferred embodiments andexamples, it will be understood by those skilled in the art that thepresent disclosures extend beyond the specifically disclosed embodimentsto other alternative embodiments and/or uses of and obviousmodifications and equivalents thereof. In addition, while severalvariations have been shown and described in detail, other modifications,which are within the scope of these disclosures, will be readilyapparent to those of skill in the art. It is also contemplated thatvarious combinations or sub-combinations of the specific features andaspects of the embodiments may be made and still fall within the scopeof the disclosures. It should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedembodiments. Thus, it is intended that the scope of at least some of thepresent embodiments herein disclosed should not be limited by theparticular disclosed embodiments described above.

What is claimed is:
 1. A system for providing continuous flow of bloodbetween two locations in a cardiovascular system of a patient,comprising: a blood conduit having a distal portion and a proximalportion, the distal portion configured to be inserted into a bloodvessel at an insertion site and to be advanced therethrough to alocation spaced apart from the insertion site; and a connectorcomprising: a tubular body comprising a proximal portion and a distalportion, wherein the distal portion of the tubular body is configured toengage the proximal portion of the blood conduit, and wherein theproximal portion of the tubular body is configured to be inserted intoan end of a vascular graft; a flange extending from the tubular bodybetween the proximal portion of the tubular body and the distal portionof the tubular body; and a connecting device comprising first and secondmembers pivotably connected together at one end by a hinge mechanismhaving one axis of rotation mounted to the flange, wherein the first andsecond members comprise an open configuration and a first closedconfiguration providing a first gap between an inner surface of thefirst and second members and an outer surface of the proximal portion ofthe tubular body and a second closed configuration providing a secondgap between the inner surface of the first and second members and theouter surface of the proximal portion of the tubular body; wherein thefirst gap accommodates a first vascular graft having an inner perimetermatching the outer perimeter of the proximal portion of the tubular bodyand a first wall thickness and the second gap accommodates a secondvascular graft having an inner perimeter matching the outer perimeter ofthe proximal portion of the tubular body and a second wall thicknessdifferent than the first wall thickness; whereby continuous flow isprovided from grafts of different wall thicknesses through the connectorand into the blood conduit.
 2. The system of claim 1, wherein the firstand second closed configurations are for securing fluid conduits ofdifferent sizes and the first and second members have second endsdisposed away from the end pivotably connected to the flange.
 3. Thesystem of claim 2, wherein the first member has a plurality of notchesformed on a surface of the first member adjacent to the second end ofthe first member, the second end of the second member being configuredto engage the notches of the first member.
 4. The system of claim 3,wherein the connector has a first configuration in which the second endof the second member engages a first range of notches, the connectoralso having a second configuration in which the second end of the secondmember engages a second range of notches including at least one notchbetween the first range of notches and the first end of the firstmember.
 5. The system of claim 3, wherein the second member comprises asecond plurality of notches formed on a surface of the second end of thesecond member configured to engage at least one notch of the pluralityof notches of the first member.
 6. A connector for implantation in acardiovascular system, the connector comprising: a tubular bodycomprising a distal tubular body and a proximal tubular body; a flangeextending from the tubular body between the proximal tubular body anddistal tubular body; and a connecting device, comprising: a first memberhaving a first end pivotably coupled with the flange, a second enddisposed away from the first end of the first member, and a plurality ofnotches formed on a surface of the first member adjacent to the secondend of the first member; and a second member having a first endpivotably coupled with the flange, a second end disposed away from thefirst end of the second member, and a second plurality of notches formedon a surface of the second end of the second member configured to engageat least one notch of the plurality of notches of the first member tosecure an inflow component to the proximal tubular body, wherein thefirst end of the first member and the first end of the second member arepivotably connected together by a hinge mechanism having one axis ofrotation mounted to the flange, wherein the connecting device comprisesan open configuration and one or more closed configurations comprising agap between an inner surface of the first and second members and anouter surface of the proximal tubular body.
 7. The connector of claim 6,wherein the connecting device further comprises a plurality of closedconfigurations configured to secure inflow components of different sizesto the proximal tubular body.
 8. The connector of claim 6, wherein theconnective device has a first closed configuration in which the secondend of the second member engages a first range of notches, theconnecting device also having a second closed configuration in which thesecond end of the second member engages a second range of notchesincluding at least one notch between the first range of notches and thefirst end of the first member.
 9. The connector of claim 6, furthercomprising a spring disposed about the hinge mechanism, in communicationwith the first and second members, and configured to (i) maintain theconnector in an open configuration, and/or (ii) apply a force between atleast one notch of the plurality of notches of the first member and atleast one notch of the plurality of notches of the second member when ina closed configuration.
 10. The connector of claim 6, further comprisinga plurality of engagement features disposed on an outer surface of thedistal tubular body.
 11. The connector of claim 6, further comprising aplurality of engagement features disposed on the outer surface of theproximal tubular body.
 12. The connector of claim 6, further comprisingshrouds extending out from a portion of each of the first and secondmembers.
 13. The connector of claim 12, further comprising a pluralityof engagement features disposed on an inner surface of the shrouds. 14.The connector of claim 6, further comprising a first slot positionedadjacent to the second end of the first member, the first slotconfigured to enable the second end of the first member to deflect awayfrom the second end of the second member by an amount sufficient toenable the first plurality of notches to slide past the second pluralityof notches when so deflected.
 15. The connector of claim 6, furthercomprising a second slot positioned adjacent to the second end of thesecond member, the second slot configured to enable the second end ofthe second member to deflect away from the second end of the firstmember by an amount sufficient to enable the second plurality of notchesto slide past the first plurality of notches when so deflected.
 16. Theconnector of claim 6, further comprising a strain relief structureconfigured to couple with an end of the connector to form a slip fitwith the inflow component for providing strain relief to the inflowcomponent.
 17. The connector of claim 16, wherein the strain reliefstructure comprises an inner sleeve disposed about a distal end of theinflow component configured to be secured between the connecting deviceand the proximal tubular body.
 18. The connector of claim 16, whereinthe strain relief structure comprises an elastomeric distal portion anda resilient proximal portion, the elastomeric distal portion configuredto elastically expand to receive at least a portion of the connectingdevice, the resilient proximal portion configured to reduce or minimizeexcessive narrowing of the inflow component at least adjacent to theproximal tubular body.
 19. A method for coupling tubular segments in acardiovascular system, the method comprising: radially expand an end ofthe inflow component with a tissue graft dilator; engaging the end ofthe inflow component with the connector of claim 6 such that a lumen ofthe connector is in fluid communication with a lumen of the inflowcomponent; and actuating the connecting device from a disengagedconfiguration to an engaged configuration such that the inflow componentis compressed by the connecting device.
 20. The method of claim 19,further comprising: positioning a strain relief structure about theinflow component for providing strain relief to the inflow component;and coupling the strain relief structure with an end of the connector.21. A connector for fluidly coupling proximal and distal tubularsegments of a fluid conduit in a cardiovascular system, the connectorcomprising: a connector body comprising a proximal portion and a distalportion, wherein the connector body comprises an outer surface defininga first outer perimeter and an inner surface defining a lumen; a flangeextending from the connector body between the proximal portion of theconnector body and the distal portion of the connector body; aconnecting device having an open configuration and a plurality of closedconfigurations, the connecting device comprising: first and secondmembers pivotably attached together at one end by a hinge mechanismhaving one axis of rotation mounted to the flange, wherein the first andsecond members are configured to engage each other to secure the fluidconduit to the connector; wherein the plurality of closed configurationscomprises a plurality of gaps between an inner surface of the first andsecond members and the outer surface of the proximal tubular body.
 22. Akit for coupling tubular segments in a cardiovascular system, the kitcomprising: the connector of claim 6; and a tissue graft dilatorconfigured to radially expand an end of the inflow component.
 23. Thekit of claim 22, further comprising a strain relief structure configuredto couple with an end of the connector to form a slip fit with theinflow component for providing strain relief to the inflow component.24. The kit of claim 23, further comprising a silicone sleeve disposedwithin the strain relief structure configured to be positioned about theinflow component.
 25. The kit of claim 23, further comprising one ormore inflow components and/or outflow components.